Cancer Diagnosis Program | Biorepositories and Biospecimen Research Branch

Search BRD Papers

Evaluation of the Sebia CAPILLARYS 2 flex piercing for the measurement of HbA(1c) on venous and capillary blood samples.

Author(s): Heylen O, Van Neyghem S, Exterbille S, Wehlou C, Gorus F, Weets I

Publication: Am J Clin Pathol, 2014, Vol. 141, Page 867-77

PubMed ID: 24838332 PubMed Review Paper? No

Purpose of Paper

Conclusion of Paper

Studies

1. Study Purpose

   The purpose of this study was to determine the effects of analyzer type on the measurement of HbA1c in blood specimens. Capillary blood was collected by fingerprick into EDTA End-to-End capillaries, and venous blood was collected into S-Monovette potassium EDTA tubes. At least 2-3 specimens were used for each analysis, but it was not specified which analysis used capillary versus venous blood.

   Summary of Findings:

   The HbA1c levels in blanks were 2.62 mmol/mol when measured by the Sebia analyzer but increased by only 0.93 mmol/mol for every 1 mmol/mol increase with the Tosoh G7, such that at high levels, HbA1c levels were higher when measured by the Tosoh G7. Bias due to labile A1p, 280 umol/L bilirubin, 26 mmol/L triglycerides, and 33-166 g/L hemoglobin was <1 mmol/mol on both the Tosoh G8 and the Sebia analyzer, but the bias due to 1 mmol/mol carbamylated hemoglobin was down to -5mmol/L on the Tosoh G8 and <1 mmol/mol on the Sebia analyzer. While the Sebia was able to separate each of the hemoglobin variants, on the Tosoh G8, hemoglobin D was eluted just after hemoglobin A and hemoglobin E eluted with hemoglobin A.

   Biospecimens

   • Bodily Fluid - Blood

   Preservative Types

   • None (Fresh)

   Diagnoses:

   • Normal
   • Diabetes Type 1
   • Diabetes Type 2

   Platform:

   Analyte	Technology Platform
   Protein	Clinical chemistry/auto analyzer

   Pre-analytical Factors:

   Classification	Pre-analytical Factor	Value(s)
   Clinical chemistry/auto analyzer Specific	Technology platform	Sebia Tosoh G7 Tosoh G8
   Preaquisition	Biomarker level	16.6-166 g/L hemoglobin 26 mmol/L triglycerides 280 µmol/L bilirubin Carbamylated hemoglobin

   View more

2. Study Purpose

   The purpose of this study was to determine the stability of HbA1c in blood and to compare measurements in venous and capillary blood. Capillary blood was collected by fingerprick into EDTA End-to-End capillaries, and venous blood was collected into S-Monovette potassium EDTA tubes. At least 2-3 specimens were used for each analysis. For the comparison of venous and capillary blood, specimens from 30 healthy and 38 diabetic patients were included, while the stability study used 3 venous specimens with varying levels of HbA1c.

   Summary of Findings:

   HbA1c in venous blood, as measured on the Sebia analyzer, was stable for at least 8 days at 2-8°C or room temperature, regardless of the addition of hemolyzing solution. In specimens with normal initial HbA1c levels, there was no effect of storage at 30°C for 8 days, but in specimens with elevated or highly elevated initial HbA1c levels, HbA1c increased in specimens stored for 3 days or more at 30°C. The HbA1c levels were similar in capillary to venous specimens using the Sebia.

   Biospecimens

   • Bodily Fluid - Blood

   Preservative Types

   • None (Fresh)

   Diagnoses:

   • Diabetes Type 1
   • Normal
   • Diabetes Type 2

   Platform:

   Analyte	Technology Platform
   Protein	Clinical chemistry/auto analyzer

   Pre-analytical Factors:

   Classification	Pre-analytical Factor	Value(s)
   Storage	Storage duration	0 days 1 day 3 day 5 day 8 day
   Storage	Storage temperature	2-8°C Room temperature 30°C
   Biospecimen Acquisition	Anatomical location of blood draw	Vein Capillary
   Biospecimen Acquisition	Method of fluid acquisition	Venipuncture Finger/heel prick sampling

   View more